O-CREAM (Aminophylline 3%, Arginine 6%, Sildenafil 2%) | Compounded Topical Cream
Important Safety Information: O-CREAM (Aminophylline 3%, Arginine 6%, Sildenafil 2%) | Compounded Topical Cream
What is this?
This Important Safety Information summarizes key warnings and precautions for O-CREAM (Aminophylline 3%, Arginine 6%, Sildenafil 2%) Topical Cream, a compounded formulation intended for topical use. This preparation typically contains amino acids, arginine, and sildenafil to support localized blood flow and sexual wellness. This compounded topical formulation has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy and should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.
Most Serious Warnings
Product can cause:
Severe allergic reactions, including rash, hives, swelling of the face, lips, tongue, or throat
Significant drop in blood pressure, especially if used with nitrate medications
Dizziness, fainting, or lightheadedness
Chest pain or shortness of breath
Severe skin irritation or burning at the application site
Compounded topical medications may carry variability in absorption, sterility, and formulation due to limited FDA oversight.
Who Should NOT Use This Medication
Do not use this medication if you:
Have a known allergy to sildenafil, arginine, amino acids, or any ingredient in the formulation
Take nitrate medications for chest pain or heart conditions
Use guanylate cyclase stimulators
Have been advised to avoid sexual activity due to cardiovascular risk
Have severe uncontrolled heart disease or very low blood pressure
Before Using This Medication, Tell Your Healthcare Provider if You:
Have heart disease, irregular heartbeat, or a history of stroke
Have high or low blood pressure
Have liver or kidney disease
Have a history of vision problems or retinitis pigmentosa
Are pregnant, planning pregnancy, or breastfeeding
Take prescription, over the counter, or herbal medications
Use other topical products in the same area
Possible Side Effects
Common (mild to moderate):
Local redness, warmth, tingling, or mild burning at the application site
Headache
Flushing
Mild dizziness
Nasal congestion
Serious (seek medical care immediately):
Signs of an allergic reaction such as swelling, rash, or difficulty breathing
Severe dizziness or fainting
Chest pain
Sudden vision or hearing changes
Prolonged or painful genital symptoms
While Using This Medication
Tell your healthcare provider immediately if you:
Experience chest pain or pressure during sexual activity
Develop severe skin irritation or blistering
Feel faint or lightheaded
Notice vision or hearing changes
Do not experience expected improvement or develop new symptoms
How Should I Use This Medicine?
Always use your customized compounded medication exactly as your doctor or healthcare provider has instructed based on the label on your medication. This is a cream dosage form intended for topical administration only. Apply only to the area directed by your provider. Wash hands before and after application. Do not apply to broken or irritated skin unless directed. If you are unsure how to use this medication, speak with your healthcare provider or pharmacist.
Missed Dosage
If you miss a scheduled application:
Apply the missed dose when you remember, unless it is close to the next scheduled dose
Skip the missed dose if it is near the time for your next application
Do not apply extra medication to make up for a missed dose
Storage
Store at room temperature unless otherwise directed on the label
Keep the container tightly closed
Protect from excessive heat and light
Keep out of reach of children and pets
Medication Disposal
Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains. Contact your pharmacy for disposal instructions or ask about medication take back programs.
Provider Oversight and Order Review
This compounded medication requires review and oversight by a licensed healthcare provider. Dosing instructions and duration of therapy must be discussed directly with your provider to ensure safety and appropriateness. Orders may be adjusted based on your medical history, response to therapy, or treatment goals.
Telemedicine Disclosure
If this prescription was issued via telemedicine, contact your prescribing clinician if you experience concerning or severe symptoms. Seek emergency medical care for urgent reactions.
Disclaimer
This summary does not include all information about O-CREAM (Aminophylline 3%, Arginine 6%, Sildenafil 2%) Topical Cream and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy. You are encouraged to report negative side effects of prescription drugs to the FDA by MedWatch or calling 1-800-FDA-1088.
